What side effects are associated with this type of intervention?

Minimally invasive surgical procedures, including those performed with robotic systems like the da Vinci SP1098, generally result in fewer side effects compared to traditional open surgeries. Common side effects may include mild pain, minor bleeding, and temporary swelling at the incision site. Patients might also experience a warm sensation, numbness, or tingling in the operated area. Serious complications are rare but can include infection, injury to surrounding tissues, and adverse reactions to anesthesia. Overall, these procedures aim to minimize recovery time and reduce the risk of complications.

What prior FDA approvals exist?

The FDA has approved several robotic and minimally invasive surgical devices aimed at reducing patient recovery time and surgical complications. Notably, the da Vinci Surgical System, which includes various models like the da Vinci Xi and Si, has been widely used for procedures requiring precision and minimal invasiveness. These systems allow surgeons to perform complex surgeries through small incisions, enhancing recovery and reducing pain. The approval of these devices has paved the way for advancements like the da Vinci SP1098, which further minimizes invasiveness by enabling single-port entry surgeries.

What other types of research exist?

Promising alternatives to the da Vinci SP1098 robotic device for less invasive surgical procedures through a single-port entry include: 1) Endoscopically-delivered miniaturized stimulators that enhance slow wave regularity and amplitudes, 2) Percutaneous electrode systems for neurostimulating pulses, 3) Multichannel stimulation protocols for gastric pacing, and 4) Single-incision laparoscopic techniques using advanced laparoscopes and trocars. These alternatives offer potential benefits in terms of reduced invasiveness, improved recovery times, and fewer complications.

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Robotic Surgery

Robot-Assisted Surgery for Surgical Procedures

Phase 2

Recruiting

Led By Mehdi Moslemi-Kebria

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 30 days of operation

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a robotic system for abdominal and pelvic surgeries. It targets patients needing these surgeries because the robot can make precise movements through a small cut, resulting in less pain and quicker recovery.

Who is the study for?

This trial is for adults over 18 who are scheduled for robot-assisted abdominal or pelvic surgery and have consented to participate. It's not suitable for individuals with a BMI over 45, those who've had unsuccessful minimally invasive surgeries before, or have conditions that make such surgeries risky like severe lung disorders.

What is being tested?

The study is testing the da Vinci SP1098 robotic device in performing less invasive abdominal and pelvic surgeries through a single small incision. The goal is to see if it leads to less pain, fewer complications, and faster recovery compared to traditional methods.

What are the potential side effects?

While specific side effects aren't listed, typical risks of robot-assisted surgery may include infection at the incision site, bleeding, potential injury to surrounding organs or tissues during operation, and reactions related to anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 30 days of operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 30 days of operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 30 days of operation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Conversion of operation to laparotomy

Incidence of major surgical complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device feasibility (da Vinci SP1098 robotic system)Experimental Treatment1 Intervention

Patients undergo surgery using the da Vinci SP1098 robotic system on study.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Minimally invasive surgical treatments, such as those performed with the da Vinci SP1098 robotic device, work by allowing surgeons to conduct complex procedures through a single, small incision. This approach reduces physical trauma, leading to less pain, fewer complications, and faster recovery times. For patients, this means a quicker return to normal activities, reduced hospital stays, and an overall improvement in postoperative quality of life.

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